What are the responsibilities and job description for the Clinical Trial Management Associate III - 25-03422 position at LeadStack Inc.?
Job Title: Clinical Trials Management Associate III
Duration: 12 months
Location: Santa Monica, CA 90404
PR: $60/hr - $65/hr on W2
- Working mostly remote but subject to change to comply with client policy.
Description:
Specific Job Responsibilities:
Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required:
- Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines
- Assists in CRO or vendor selection
- With guidance from supervisor coordinates CROs or vendors
- Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
- Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
- Participate or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams (May participate in abstract presentations, oral presentations and manuscript development)
- Interfaces with individuals in other functional areas to address routine study issues
- May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants
- Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives
- Travel is required
- Excellent verbal, written, interpersonal and presentation skills are required
- Working knowledge and experience with Word, PowerPoint and Excel
- Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
- Ability to develop tools and processes that increase measured efficiencies of the project
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
- Must have a general understanding of functional issues and routine project goals from an organizational perspective.
Specific Education & Experience Requirements:
- 4 years of experience and a BS or BA in a relevant scientific discipline
- 4 years of experience and an RN (2 or 3 year certificate)
- CCRA or other certification desired
Salary : $60 - $65